The following data is part of a premarket notification filed by Marketing Professionals In Medicine, Inc. with the FDA for Mpm Gelpad (hydrogel Saturated Sterile Gauze Pads).
Device ID | K933495 |
510k Number | K933495 |
Device Name: | MPM GELPAD (HYDROGEL SATURATED STERILE GAUZE PADS) |
Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
Applicant | MARKETING PROFESSIONALS IN MEDICINE, INC. P.O.BOX 16598 Ft. Worth, TX 76162 -0598 |
Contact | Richard A Hammer |
Correspondent | Richard A Hammer MARKETING PROFESSIONALS IN MEDICINE, INC. P.O.BOX 16598 Ft. Worth, TX 76162 -0598 |
Product Code | MGQ |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-07-19 |
Decision Date | 1994-01-12 |